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NCT Number: NCT07479745

Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019

The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019

Recruiting

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Key information

Conditions

Healthy Male Volunteers

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location status: Recruiting

Location contact

Philip Evans, MBChB, MRCS (Ed)

CONTACT

+44 (0) 330 303 1000

Philip Evans, MBChB, MRCS (Ed)

PRINCIPAL_INVESTIGATOR

Quotient Sciences Recruitment

CONTACT

[email protected]

+44 (0) 330 303 1000

About this study

This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Aged 30 to 65 years inclusive at the time of signing informed consent

Exclusion criteria

  • Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
  • Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
  • History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly gastrointestinal (GI) disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome, neurological or psychiatric disorder, or clinically significant dermatological disorder
  • History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)

Treatment and study plan

[14C]GRT6019

Drug

Single administration in a single dosing period.

Other names: Tegacorat, GRM-01, GRT6019

Primary outcomes

  1. Cumulative amount of total radioactivity excreted (CumAe)

    Time frame: Day -1 (Admission), Day 1 up to Days 47-48.

    To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019

  2. Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae)

    Time frame: Day -1 (Admission), Day 1 up to Days 47-48.

    To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019

  3. Metabolite profling and structural identification

    Time frame: Day -1 (Admission), Day 1 up to Days 47-48.

    To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples

Study contacts

Contact information is provided by the study sponsor or research team.

Grünenthal Clinical Trial Information

CONTACT

[email protected]

+49 241 569 3223

Transparency and Public Disclosure Coordinator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Grünenthal GmbH

Industry

Registry information

Official study title

An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 in Healthy Male Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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